To evaluate the Low Density Lipoprotein-Cholesterol (LDL-C) lowering effect of PF-04950615 administered subcutaneously at monthly intervals, or twice monthly intervals in subjects with high cholesterol whose LDL-cholesterol is >/=80 mg/dL on background treatment with a statin.

A Phase 2B Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose-Ranging Study To Assess The Efficacy, Safety And Tolerability Of PF-04950615 (RN316) Following Monthly And Twice Monthly Subcutaneous Dosing For Six Months In Hypercholesterolemic Subjects On A Statin

The absolute change from baseline in Low Density Lipoprotein-cholesterol at the end of week 12 following randomization [ Time Frame: end of week 12 post randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Low Density Lipoprotein-Cholesterol (LDL-C) will be assessed as change and % change from baseline at the end of week 12 following randomization [ Time Frame: Week 12 and 24 ] [ Designated as safety issue: No ]

Total cholesterol will be assessed as change and % change from baseline at the end of week 12 following randomization [ Time Frame: Week 12 and 24 ] [ Designated as safety issue: No ]

Apolipoprotein B (ApoB) will be assessed as change and % change from baseline at the end of week 12 following randomization [ Time Frame: Week 12 and 24 ] [ Designated as safety issue: No ]

Apolipoprotein A1 (ApoA1), Apolipoprotein AII (ApoAII) will be assessed as change and % change from baseline at the end of week 12 following randomization [ Time Frame: Week 12 and 24 ] [ Designated as safety issue: No ]

Lipoprotein (a) (Lp(a)) will be assessed as change and % change from baseline at the end of week 12 following randomization [ Time Frame: Week 12 and 24 ] [ Designated as safety issue: No ]

High Density Lipoprotein (HDL)-cholesterol will be assessed as change and % change from baseline at the end of week 12 following randomization [ Time Frame: Week 12 and 24 ] [ Designated as safety issue: No ]

Very Low Density Lipoprotein (VLDL)-cholesterol will be assessed as change and % change from baseline at the end of week 12 following randomization [ Time Frame: Week 12 and 24 ] [ Designated as safety issue: No ]

Triglycerides will be assessed as change and % change from baseline at the end of week 12 following randomization [ Time Frame: Week 12 and 24 ] [ Designated as safety issue: No ]

non-HDL-cholesterol will be assessed as change and % change from baseline at the end of week 12 following randomization [ Time Frame: Week 12 and 24 ] [ Designated as safety issue: No ]

A total of 7 dose groups in two dosing schedules, 50 subjects per dose group are planned. Q28d dose group will receive subcutaneous administration of PF-04950615 or Placebo once a month.

Drug: PBO

Placebo Q28d

Drug: 200mg PF-04950615 (RN316)

PF-04950615 200 mg, Q28d

Other Name: PF-04950615 (RN316)

Drug: 300mg PF-04950615 (RN316)

PF-04950615 300 mg, Q28d

Other Name: PF-04950615 (RN316)

Experimental: Q14d Dosing Arm

A total of 7 dose groups in two dosing schedules, 50 subjects per dose group are planned. Q14d dose group will receive subcutaneous administration of PF-04950615 or Placebo every 2 weeks.

Drug: PBO

Placebo, Q14d

Drug: PF-04950615

PF-04950615 50mg, Q14d

Other Name: PF-04950615 (RN316)

Drug: PF-04950615

PF-04950615 100 mg, Q14d

Other Name: PF-04950615 (RN316)

Drug: PF-04950615

PF-04950615 150mg, Q14d

Other Name: PF-04950615 (RN316)

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Subjects should be receiving a stable dose (at least 6 weeks) of any statin and continue on same dose of statin for the duration of this trial.

Lipids should meet the following criteria on a background treatment with a statin at 2 screening visits that occur at screening and at least 7 days prior to randomization on Day 1:

Fasting LDL-C greater than or equal to 80 mg/dL (2.31 mmol/L);

Fasting TG less than or equal to 400 mg/dL (4.52 mmol/L).

Subject's fasting LDL-cholesterol must greater than or equal to 80 mg/dL (2.31 mmol/L at the initial screening visit, and the value at the second visit within 7 days of randomization must be not lower than 20% of this initial value to meet eligibility criterion for this trial.

Exclusion Criteria:

Participation in other studies within 3 months before the current study begins and/or during study participation.

Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

Pregnant females; breastfeeding females; males and females of childbearing potential not using highly effective contraception or not agreeing to continue highly effective contraception for at least 63 days after last dose of investigational product.

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01592240